FDA.report

AESCULAP

Primary DI
04038653179985
Brand
AESCULAP
Company
Aesculap AG
Model
OM660R
Catalog number
OM660R
Device description
HURD Tonsil Dissector, 8 1/2", (215 mm), double ended, width: 6 mm, non-sterile, reusable
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KBMDISSECTOR, TONSIL

Product Code Classifications

CodeDeviceSpecialtyClass
KBMDissector, TonsilEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653179985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653179985040386531799854038653179985

GMDN Terms

TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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